RecruitingPhase 2NCT07528274

Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure

Microwave Ablation in Combination With Tislelizumab and Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer After Progression Following First-Line Immunotherapy Plus Chemotherapy: A Prospective, Single-Arm, Phase II Study

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

20 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)NSCLC (Non-small Cell Lung Cancer)

Summary

The purpose of this clinical trial is to evaluate progression-free survival (PFS) of microwave ablation in combination with tislelizumab and docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have progressed following first-line immunotherapy combined with chemotherapy. Participants with advanced NSCLC who experienced disease progression after first-line immunotherapy plus chemotherapy will receive the following treatments: 1. Tislelizumab: 200 mg administered intravenously every 3 weeks (Q3W) 2. Docetaxel: 75 mg/m² administered intravenously every 3 weeks (Q3W) for 4-6 cycles 3. Microwave ablation, administered per protocol

Eligibility

Min Age: 18 Years

Inclusion Criteria14

Patients with cytologically or histologically confirmed non-small cell lung cancer (NSCLC), classified as stage IIIB, IIIC, or IV (AJCC 9th edition) and not eligible for curative treatment.
Male or female patients aged ≥18 years who have provided written informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of more than 6 months, and deemed suitable for microwave ablation by the investigator.
Patients must have previously received first-line treatment with tislelizumab in combination with chemotherapy and have documented disease progression based on imaging assessments prior to enrollment. Disease progression must occur ≥6 months after initiation of first-line tislelizumab plus chemotherapy, with or without concomitant anti-angiogenic therapy.
Adequate organ and bone marrow function, defined as follows:
Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelet count ≥100 × 10⁹/L Hemoglobin ≥90 g/L White blood cell count ≥3.0 × 10⁹/L
Hepatic function:
Total bilirubin <1.5 × the upper limit of normal (ULN) Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT), and alkaline phosphatase (ALP) ≤2.5 × ULN In patients with liver metastases: AST and ALT ≤5.0 × ULN In patients with liver and/or bone metastases: ALP ≤5.0 × ULN
Renal function:
Serum creatinine ≤1.5 × ULN Urine protein <2+ on urinalysis; if baseline urine protein is ≥2+, a 24-hour urine protein ≤1.0 g is required
Coagulation function:
International normalized ratio (INR) ≤1.5 Activated partial thromboplastin time (aPTT) ≤1.5 × ULN
Cardiac function defined as left ventricular ejection fraction (LVEF) ≥50%.
Ability to communicate effectively with the investigator and to comply with study-related visits, treatment, laboratory tests, and other study requirements.

Exclusion Criteria14

Participants meeting any of the following criteria will be excluded from the study:
Diagnosis of small cell lung cancer (SCLC), including mixed small cell and non-small cell lung cancer.
Presence of symptomatic brain metastases at the start of treatment.
Concurrent participation in another interventional clinical trial for cancer treatment.
History of tracheoesophageal fistula, gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess within 6 months prior to treatment initiation.
Presence of severe cardiovascular or cerebrovascular disease, including but not limited to:
Cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction, or significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization; Unstable angina; Heart failure classified as New York Heart Association (NYHA) class ≥ II; Mean resting corrected QT interval (QTc) >470 ms; Any clinically significant resting electrocardiogram (ECG) rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree atrioventricular (AV) block, second-degree AV block, or PR interval >250 ms; Any factors that increase the risk of QTc prolongation or arrhythmic events, including heart failure, electrolyte abnormalities (serum/plasma potassium < LLN; magnesium < LLN; calcium < LLN), congenital long QT syndrome, family history of long QT syndrome, unexplained sudden death of a first-degree relative before the age of 40, or concomitant use of medications known to prolong the QT interval and induce torsades de pointes.
Major surgical procedures performed within 4 weeks prior to enrollment or planned during the study period.
Bleeding tendency, high risk of bleeding, or coagulation disorders, including thrombotic events within 6 months prior to randomization and/or history of hemoptysis within 3 months prior to randomization (defined as ≥2.5 mL per episode).
Presence of unhealed wounds, active gastrointestinal ulcers, or fractures (excluding healed historical fractures).
Known or suspected hypersensitivity to tislelizumab and/or any of its excipients.
Pregnant or breastfeeding women.
Women of childbearing potential or male participants who are unwilling to use effective contraception during the study and for 6 months after the last dose of study treatment.
Any other condition that, in the opinion of the investigator, would render the participant unsuitable for enrollment in this study.

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Interventions

DRUGTislelizumab

Tislelizumab will be administered at a dose of 200 mg intravenously every 3 weeks (Q3W). Treatment will be continued according to the study protocol until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.

DRUGDocetaxel

Docetaxel will be administered at a dose of 75 mg/m² intravenously every 3 weeks (Q3W) for a total of 4 to 6 cycles, unless discontinued earlier due to disease progression, unacceptable toxicity, or other protocol-defined criteria.

OTHERMicrowave ablation

Microwave ablation will be performed concurrently with systemic treatment. The timing and specific procedural details will be determined by the investigator according to clinical practice and patient condition. There is no predefined limit on the number of microwave ablation sessions. In general clinical practice, microwave ablation is delivered at an output power of approximately 40-60 W for a duration of 5-10 minutes per session, with 1 to 3 tumor lesions treated during a single procedure.